Periampullary malignant and benign diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. subjects with informed consent; 2. pancreatic head and ampulla lesions underwent pancreatoduodenectomy; 3. male or female subjects, more than 18 years of age, life expectancy of at least 12 weeks; 4. in the 7 days before surgery, suffecient liver and kidney function, laboratory indexes suitable (after treatment): neutrophil 1500/mm3, PLT = 50x10^9/L, ALB = TBIL<2mg/dL, serum 28g/L, ALT, AST<5 times the upper limit of normal value, the upper limit of normal Bun, Cr<1.5 times the value of INR<1.7 or PT extension <4s.
Exclusion criteria
Exclusion criteria: 1. distant organs (liver, lung, abdominal) metastasis has occurred; the common bile duct and hepatic duct metastasis; hepatic portal, common bile duct and pancreatic lymph node metastasis above; tumor involvement of the superior mesenteric artery and celiac trunk; around pancreatic head or ampulla with inferior vena cava or aortic close adhesion; 2. Congestive heart failure 2 > New York Heart Association (NYHA) grade II; 3. had uncontrolled hypertension; 4. human immunodeficiency virus (HIV) infection history; 5. renal failure or renal insufficiency; 6. serious infectious clinical activities of blood or peritoneal dialysis (grade >2, NCI-CTCAE version 4); 7. patients 4 weeks before the emergence of upper gastrointestinal bleeding or clear gastrointestinal bleeding tendency; 8. pregnancy or breast-feeding subjects; 9. before the trial started within 4 weeks after surgery the patients or patients has not yet recovered from the side effects of this kind of operation; 10. with its malignant tumor (he had cure 3 years ago could be included).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POPF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complication;Delayed Gastric Emptying;Postoperative hospital stay; | — |
Countries
China